Individualized Medicine

1. Front Matter

   Pages i-xv

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2. Introduction

   • Tobias Fischer, Martin Langanke, Paul Marschall, Susanne Michl

   Pages 1-7

3. Definition and Concept of Individualized Medicine

   1. Front Matter

      Pages 9-9

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   2. The Meaning of “Individualized Medicine”: A Terminological Adjustment of a Perplexing Term

      • Martin Langanke, Wolfgang Lieb, Pia Erdmann, Marcus Dörr, Tobias Fischer, Heyo K. Kroemer et al.

      Pages 11-28

   3. Individualized Medicine Within the GANI_MED Project

      • Hans-Jörgen Grabe, Henri Wallaschofski

      Pages 29-42

4. Perspectives of Socio-Cultural and Historical Studies

   1. Front Matter

      Pages 43-43

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   2. Inventing Traditions, Raising Expectations. Recent Debates on “Personalized Medicine”

      • Susanne Michl

      Pages 45-60

   3. The Epistemics of “Personalized Medicine”. Rebranding Pharmacogenetics

      • Susanne Michl

      Pages 61-78

5. Medical Perspectives

   1. Front Matter

      Pages 79-79

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   2. Use of Biomarkers for the Prediction of Treatment Response: Immunoadsorption in Dilated Cardiomyopathy as a Clinical Example

      • Marcus Dörr, Uwe Völker, Stephan B. Felix

      Pages 81-92

   3. The Role of Pharmacogenomics in Individualized Medicine

      • Henriette E. Meyer zu Schwabedissen

      Pages 93-112

6. Concept-Based Ethical Questions

   1. Front Matter

      Pages 113-113

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   2. On a Philosophy of Individualized Medicine: Conceptual and Ethical Questions

      • Konrad Ott, Tobias Fischer

      Pages 115-163

   3. The Concept of Disease in the Era of Prediction

      • Johann-Christian Põder, Heinrich Assel

      Pages 165-180

7. Applied Research Ethics

   1. Front Matter

      Pages 181-181

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   2. Informed Consent in GANI_MED—A Sectional Design for Clinical Epidemiological Studies Within Individualized Medicine

      • Jakob Fasold, Pia Erdmann, Roberto Lorbeer, Wenke Liedtke, Martin Langanke

      Pages 183-208

   3. Ethics Meets IT: Aspects and Elements of Computer-based Informed Consent Processing

      • Thomas Bahls, Wenke Liedtke, Lars Geidel, Martin Langanke

      Pages 209-229

   4. Handling Incidental Findings from Imaging Within IM Related Research—Results from an Empirical-Ethical Study

      • Pia Erdmann

      Pages 231-250

8. Health Economic Assessment of Individualized Medicine

   1. Front Matter

      Pages 251-251

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   2. Individualized Medicine: From Potential to Macro-Innovation

      • Steffen Flessa, Paul Marschall

      Pages 253-271

In 2009 the University Medicine Greifswald launched the “Greifswald Approach to Individualized Medicine” (GANI_MED) to implement biomarker-based individualized diagnostic and therapeutic strategies in clinical settings. Individualized Medicine (IM) has led not only to controversies about its potentials, but also about its societal, ethical and health economic implications. This anthology focusses on these areas and includes – next to clinical examples illustrating how the integrated analysis of biomarkers leads to significant improvement of therapeutic outcomes for a subgroup of patients – chapters about the definition, history and epistemology of IM. Additionally there is a focus on conceptual philosophical questions as well as challenges for applied research ethics (informed consent process, the IT-based consent management and the handling of incidental findings). Finally it pays attention to health economic aspects. The possibilities of IM to initiate a paradigm shift in the Germanhealth care provision are investigated. Furthermore, it is asked whether the G-DRG system is ready for the implementation of such approaches into clinical routine.

• Biomarkers
• Health Economics
• Individualized Medicine
• Personalised Medicine
• Research Ethics

“This collection of essays is an interdisciplinary effort to provide a comprehensive overview of individualized medicine. … it is relevant for global researchers and practitioners of individualized medicine. … By carefully gathering a diverse collection of essays, the editors provide us with a much-needed, comprehensive analysis of individualized medicine.” (Kathrine Bendtsen, Doody’s Book Reviews, October, 2015)

• University Medicine Greifswald, Department for Ethics, Theory and History in Life Sciences, Greifswald, Germany

  Tobias Fischer

• University of Greifswald, GANI_MED – Greifswald Approach to Individualized Medicine, Greifswald, Germany

  Martin Langanke, Paul Marschall

• University Medicine of Johannes Gutenberg-University Mainz, Institute for History, Theory and Ethic of Medicine, Mainz, Germany

  Susanne Michl

Policies and ethics